Cambridge Isotope Laboratories, Inc. is deploying the Accelrys Laboratory Execution System (LES) and three applications within the Accelrys Laboratory Information Management System.

Accelrys, Inc. has announced that Cambridge Isotope Laboratories, Inc. (CIL) is deploying the Accelrys Laboratory Execution System (LES) and three applications within the Accelrys Laboratory Information Management System (LIMS) to enhance quality control and regulatory compliance as the company experiences increased demand for its products. The full enterprise deployment of these applications, which are a part of the Accelrys Process Management and Compliance Suite, is progressing well following the successful completion of a comprehensive pilot. The pilot phase resulted in a 28 percent improvement in productivity or test execution time and a 78 percent reduction in data review times, ultimately enabling CIL to improve lab processing time by 40 percent.

"As a world leader in the production of stable isotope applications, CIL understands that developing and commercializing innovative products in an efficient, cost-effective and compliant manner requires an entirely new approach to the lab-to-commercialization process," said Ken Rapp, managing director of Accelrys' analytical, development, quality and manufacturing solutions group. "By connecting lab-to-plant workflows and taking a process- and execution-centric approach to LIMS implementations, CIL benefits from the flexibility needed to manage its rapidly growing business and the highly efficient process execution required to produce quality cGMP products."

CIL develops, produces and markets stable, non-radioactive isotopes and chemical components for the specialty chemicals, research products, environmental standards and clinical research industries. Producing products that meet cGMP requirements is essential to its business. GMP compliance is an expensive and time-consuming practice, and with customer demand driving increasing production, CIL's manual processes were no longer keeping pace with the company's needs.

CIL's goal for the project is to automate its Andover/Tewksbury, Mass. laboratories by implementing existing laboratory procedures into the Accelrys LES and integrating the Accelrys Metrology and Calibration Management, Accelrys Sample and Specification Management and Accelrys Inventory Management applications with the Accelrys LES at the benchtop and analyst review level to better manage lab data. In the process CIL is going paperless. As a result of the implementation analysts will be able to capture and secure data electronically, analyze trends automatically and perform quality control reviews and approvals on a single review screen. When complete the implementation is expected to reduce batch release times and shorten review and calculation times, ultimately allowing CIL to commercialize high quality, highly compliant products faster and more efficiently.

"At CIL, we have an unwavering commitment to quality and cGMP practices, and we need a product and process informatics partner and solution that are reflective of those values," said CIL Chief Executive Officer Joel C. Bradley. "By automating our lab processes with the Accelrys LES and Accelrys LIMS, we're truly transforming the way we work. The Accelrys solutions will allow us to focus far more on scientific innovation and far less on bureaucratic record keeping. Most importantly, we're meeting the growing demand for our cGMP products while reducing compliance risk."

The Accelrys LES is an automated compliance system for procedure execution that eliminates paper documentation and simplifies quality assurance review and approval. By deploying the Accelrys LES, organizations have significantly reduced operational costs and review and reporting times. The elimination of lab errors also reduces rework loops. The Accelrys LIMS is a process-centric LIMS with a specific focus on scale-up, manufacturing and compliance that eliminates the complexities, excessive customization and lengthy associated validation requirements inherent with legacy LIMS. Accelrys LIMS offers off-the-shelf capabilities for metrology and calibration, stability, sample and specifications, inventory, environmental monitoring and work request management.

Both the Accelrys LES and Accelrys LIMS are part of the Accelrys Process Management and Compliance Suite, a comprehensive software suite for capturing, managing and analyzing development and process data for operational excellence in new product development and commercial quality operations.

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